Medical appliance with layered base plate and/or sensor assembly part and related methods

ABSTRACT

Embodiments disclosed herein relate to a base plate and/or a sensor assembly part of an ostomy appliance. In embodiments, the base plate and/or the sensor assembly part comprises a first adhesive layer, a masking element, and a plurality of electrodes. The first adhesive layer includes a stomal opening with a center point and a proximal surface configured to be attached to a skin surface of a user. The masking element is arranged on a distal surface of the first adhesive layer, and is more insulative than the first adhesive layer. Further, the plurality of electrodes are arranged on a distal side of the first adhesive layer. Each electrode includes a sensing part and a conductor part and the masking element is arranged between the conductor parts and the first adhesive layer.

The present disclosure relates to an ostomy system, devices thereof andmethod for manufacturing an ostomy appliance. The ostomy appliancesystem comprises an ostomy appliance and an ostomy monitor device. Inparticular, the present disclosure relates to a base plate and/or asensor assembly part of an ostomy appliance including electrodes fordetecting and monitoring the operation of an ostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate and/or a sensorassembly part,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8 ,

FIG. 10 is a distal view of a part of the base plate and/or sensorassembly part including a monitor interface.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer, the accessory device, and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of moisture propagation in the adhesivematerial provided for attaching the base plate to the skin surface of auser. Depending on the nature of the pattern of moisture propagation inthe adhesive, the ostomy system and devices thereof enable providinginformation to the user about the type of failure, and in turn enableproviding an indication to the user of the severity and thus theremaining time frame for replacing the ostomy appliance withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The ostomy appliance includes a base plate, such as a monolithic,one-piece base plate, e.g. integrated with a sensor assembly part, or abase plate and a separate sensor assembly part, such as a sensorassembly part to be subsequently applied to a base plate. For example,to allow an arbitrary base plate, such as a conventional base plate, toachieve the features as described herein. Features as described withrespect to the base plate herein may be provided by a sensor assemblypart to be applied to a base plate, e.g. by the user. A sensor assemblypart may be adapted to adhere to an ostomy plate.

A disclosed method of attaching a base plate to a user's stoma and/orskin surrounding the stoma, such as the peristomal skin area, maycomprise attaching a sensor assembly part to a base plate and attachingthe base plate, e.g. together with the attached sensor assembly part, tothe user's stoma and/or skin surrounding the stoma, such as theperistomal skin area. Alternatively, the method of attaching the baseplate to the user's stoma and/or skin surrounding the stoma may compriseattaching the sensor assembly part to the user's stoma and/or skinsurrounding the stoma and attaching the base plate to the user's stomaand/or skin surrounding the stoma above the attached sensor assemblypart.

The base plate and/or the sensor assembly part may comprise a firstadhesive layer, also denoted center adhesive layer. During use, thefirst adhesive layer adheres to the user's skin (peristomal area) and/orto additional seals, such as sealing paste, sealing tape and/or sealingring. Thus, the first adhesive layer may be configured for attachment ofthe base plate and/or the sensor assembly part to the skin surface of auser. The first adhesive layer may have a stomal opening, such as afirst adhesive stomal opening, with a center point.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocolloids. The first composition may comprise one or more watersoluble or water swellable hydrocolloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The firstcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The first composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is optionallyconfigured to overlap a part of an electrode, e.g. to form a sensorpoint.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap parts of an electrode and the primarysecond sensor point openings configured to overlap parts of anotherelectrode different from the electrode at least partly overlapped by theprimary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap parts of an electrode and thesecondary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap parts of an electrode and thetertiary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate and/or the sensor assembly part may comprise a secondlayer. The second layer may be an adhesive layer, also denoted rimadhesive layer. The second layer may have a second radial extension thatis larger than a first radial extension of the first adhesive layer atleast in a first angular range of the base plate and/or the sensorassembly part. Accordingly, a part of a proximal surface of the secondlayer may be configured for attachment to the skin surface of a user.The part of a proximal surface of the second layer configured forattachment to the skin surface of a user is also denoted the skinattachment surface of the second adhesive layer. The second layer mayhave a stomal opening, such as a second layer stomal opening and/or asecond adhesive stomal opening, with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocolloids. The second composition may comprise one or morewater soluble or water swellable hydrocolloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethylcellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocolloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively or additionally, thesecond adhesive layer may be thinner than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lessmouldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate and/or the sensor assembly part may comprise one or moreelectrodes, such as a plurality of electrodes, such as two, three, four,five, six, seven or more electrodes. The sensor assembly part may beapplied to the base plate, such as to provide the base plate with theone or more electrodes.

The electrodes, e.g. some or all the electrodes, may be arranged betweenthe first adhesive layer and the second adhesive layer. The electrodesmay be arranged in an electrode assembly, e.g. an electrode layer. Inembodiments, the electrode layer may be formed as a water sealing or awater transparent structure to allow water transport from the firstadhesive layer to the second adhesive layer. An electrode comprises aconnection part for connecting the electrodes to other components and/orinterface terminals/terminal elements. An electrode may comprise one ormore conductor parts and/or one or more sensing parts. A conductor partmay be considered part of an electrode connecting two or more sensingparts, and/or connecting a sensing part with a connection part of therespective electrode. A sensing part may be considered a part of theelectrode being suitable for sensing, e.g. liquid, such as liquidcontent, and/or output, such as output resulting from a leakage, or animminent leakage. The sensing part may be suitable for sensing e.g. byits shape, said shape potentially being circular, oval, or rectangular.Thus, the conductor part may conduct a signal arising from the sensingpart. An electrode may comprise alternating conductor parts and sensingparts. The electrode assembly may be arranged between the first adhesivelayer and the second adhesive layer. The base plate and/or the sensorassembly part, e.g. the electrode assembly, may comprise a firstelectrode, a second electrode and optionally a third electrode. The baseplate and/or the sensor assembly part, e.g. the electrode assembly, maycomprise a fourth electrode and/or a fifth electrode. The base plateand/or the sensor assembly part, e.g. the electrode assembly, optionallycomprises a sixth electrode. The base plate and/or the sensor assemblypart, e.g. the electrode assembly, may comprise a ground electrode. Theground electrode may comprise a first electrode part. The firstelectrode part of the ground electrode may form a ground for the firstelectrode. The ground electrode may comprise a second electrode part.The second electrode part of the ground electrode may form a ground forthe second electrode. The ground electrode may comprise a thirdelectrode part. The third electrode part of the ground electrode mayform a ground for the third electrode. The ground electrode may comprisea fourth electrode part. The fourth electrode part of the groundelectrode may form a ground for the fourth electrode and/or the fifthelectrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Theelectrode assembly, such as the support layer of the electrode assembly,may have a stomal opening, such as an electrode assembly stomal openingand/or a support layer stomal opening, with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates and/or sensor assembly parts, the support layer ismade of thermoplastic polyurethane (TPU). The support layer material maybe made of or comprise one or more of polyester, a thermoplasticelastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA),polyurea, and silicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly part, such as the electrodeassembly may comprise a masking element configured to insulate at leastparts of the electrodes from the first adhesive layer of the base plateand/or the sensor assembly part. Thus, the masking element may be moreinsulative, such as less electrically conductive and/or lessmoisture-permeable than other layers of the base plate and/or sensorassembly part, such as more insulative than the first adhesive layer.The masking element may be arranged between the electrodes and the firstadhesive layer. For example, the masking element may be arranged betweenthe conductor parts of the plurality of electrodes and the firstadhesive layer. Alternatively or additionally, the masking elementoptionally is not arranged between the sensing parts of the plurality ofelectrodes and the first adhesive layer, e.g. the masking element may bearranged such as to not separate the sensing parts of the plurality ofelectrodes and the first adhesive layer.

The masking element may comprise one or more, such as a plurality of,sensor point openings. The sensor point openings may comprise primarysensor point openings and/or secondary sensor point openings. The sensorpoint openings may comprise tertiary sensor point opening(s). The sensorpoint openings may comprise quaternary sensor point opening(s) A sensorpoint opening of the masking element overlaps at least one electrode ofthe electrode assembly when seen in the axial direction, e.g. to form asensor point. For example, a primary sensor point opening may overlap apart of the ground electrode and/or a part of the fourth electrode. Asecondary sensor point opening may overlap a part of the fourthelectrode and/or a part of the fifth electrode. A tertiary sensor pointopening may overlap a part of the fifth electrode and/or a part of theground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. The masking element may comprise polymeric (e.g.polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica)materials. In one or more exemplary base plates and/or sensor assemblyparts, the masking element is made of or comprises thermoplasticpolyurethane (TPU). In one or more exemplary base plates and/or sensorassembly parts, the masking element is made of or comprises polyester.The masking element material may be made of or comprise one or more ofpolyester, a thermoplastic elastomer (TPE), polyimide, polyimide,Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly part may comprise a firstintermediate element. The first intermediate element may be arrangedbetween the electrodes/electrode layer and the first adhesive layerand/or between the second layer and the first adhesive layer. The firstintermediate layer may be made of an insulating material.

The base plate and/or the sensor assembly part may comprise a releaseliner. The release liner is a protective layer that protects adhesivelayer(s) during transport and storage and is peeled off by the userprior to applying the base plate and/or the sensor assembly part on theskin. The release liner may have a stomal opening, such as a releaseliner stomal opening, with a center point.

The base plate and/or the sensor assembly part may comprise a top layer.The top layer is a protective layer protecting the adhesive layer(s)from external strains and stress when the user wears the ostomyappliance. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the top layer. The toplayer may have a stomal opening, such as a top layer stomal opening,with a center point. The top layer may have a thickness in the rangefrom 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, suchas 0.04 mm.

The base plate and/or the sensor assembly part may comprise a monitorinterface. The monitor interface may be configured for electricallyand/or mechanically connecting the ostomy appliance (base plate and/orsensor assembly part) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (base plateand/or sensor assembly part) to the monitor device. Thus, the monitorinterface of the base plate and/or the sensor assembly part isconfigured to electrically and/or mechanically couple the ostomyappliance and the monitor device.

The monitor interface of the base plate and/or of the sensor assemblypart may comprise, e.g. as part of a first connector of the monitorinterface, a coupling part for forming a mechanical connection, such asa releasable coupling between the monitor device and the base plateand/or the sensor assembly part. The coupling part may be configured toengage with a coupling part of the monitor device for releasablycoupling the monitor device to the base plate and/or the sensor assemblypart.

The monitor interface of the base plate and/or the sensor assembly partmay comprise, e.g. as part of a first connector of the monitorinterface, a plurality of terminals, such as two, three, four, five,six, seven or more terminals, for forming electrical connections withrespective terminals of the monitor device. The monitor interface maycomprise a ground terminal element forming a ground terminal. Themonitor interface may comprise a first terminal element forming a firstterminal, a second terminal element forming a second terminal andoptionally a third terminal element forming a third terminal. Themonitor interface may comprise a fourth terminal element forming afourth terminal and/or a fifth terminal element forming a fifthterminal. The monitor interface optionally comprises a sixth terminalelement forming a sixth terminal. The terminal elements of the monitorinterface may contact respective electrodes of the base plate and/or thesensor assembly part, such as the electrode assembly. The firstintermediate element may be arranged between the terminal elements andthe first adhesive layer. The first intermediate element may cover oroverlap terminal element(s) of the base plate and/or the sensor assemblypart when seen in the axial direction. Thus, the first adhesive layermay be protected or experience more evenly distributed mechanical stressfrom the terminal elements of the base plate and/or the sensor assemblypart, in turn reducing the risk of terminal elements penetrating orotherwise damaging the first adhesive layer. The first intermediateelement may protect or mechanically and/or electrically shield the firstadhesive layer from the terminal elements of the base plate and/or thesensor assembly part.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate and/or the sensor assembly part may have a stomal openingwith a center point. The stomal opening of the base plate and/or thesensor assembly part may be formed collectively of stomal opening(s) ofthe layers of the base plate and/or the sensor assembly part, such as ofthe top layer, the first adhesive layer, the second layer and/or thesensor assembly part. The stomal opening(s) of the layers of the baseplate and/or the sensor assembly part, such as of the top layer, thefirst adhesive layer, the second layer and/or the sensor assembly partmay be aligned to form the stomal opening of the base plate and/or thesensor assembly part. The stomal opening may be a through-going passageof the base plate and/or the sensor assembly part. The stomal openingmay be arranged substantially in the center of the base plate and/or thesensor assembly part. The stomal opening(s) of the layers of the baseplate and/or the sensor assembly part may be arranged substantially inthe center of the respective layer. The stomal opening may be configuredto receive a stoma of the user and/or the stomal opening may beconfigured to allow output from the stoma to pass through the stomalopening an into an ostomy pouch attached to the base plate. For example,the stomal opening may be configured to allow passage of output from aproximal side of the base plate and/or sensor assembly part to a distalside of the base plate and/or sensor assembly part. The size and/orshape of the stomal opening may typically be adjusted by the user ornurse before application of the ostomy appliance to accommodate theuser's stoma. In one or more exemplary base plates, the user forms thestomal opening during preparation of the base plate for application.

The monitor device comprises a processor and one or more interfaces,such as a first interface and/or a second interface. The monitor devicemay comprise a memory for storing ostomy data.

In one or more exemplary monitor devices, the processor is configured toapply a processing scheme, the first interface is connected to theprocessor and the memory, and the first interface is configured forcollecting ostomy data from the base plate and/or the sensor assemblypart coupled to the first interface. The ostomy data may comprise one ormore, such as all, of first ostomy data from a first electrode pair ofthe base plate and/or the sensor assembly part, second ostomy data froma second electrode pair of the base plate and/or the sensor assemblypart, and third ostomy data from a third electrode pair of the baseplate and/or the sensor assembly part. A second interface is connectedto the processor. To apply a processing scheme may comprise one or moreof obtain first parameter data based on the first ostomy data; obtainsecond parameter data based on the second ostomy data; and obtain thirdparameter data based on the third ostomy data. To apply a processingscheme may comprise determining an operating state of the base plateand/or the sensor assembly part of the ostomy appliance based on one ormore, such as all, of the first parameter data, the second parameterdata and the third parameter data. The operating state may be indicativeof a degree of radial erosion of the base plate and/or the sensorassembly part, such as of the first adhesive layer, and/or an acuteleakage risk for the ostomy appliance. The monitor device is configuredto, in accordance with a determination that the operating state is afirst operating state, transmit a first monitor signal comprisingmonitor data indicative of the first operating state of the base plateand/or the sensor assembly part via the second interface; and/or inaccordance with a determination that the operating state is a secondoperating state, transmit a second monitor signal comprising monitordata indicative of the second operating state of the base plate and/orthe sensor assembly part via the second interface.

In one or more exemplary monitor devices, the first operating state ofthe base plate and/or the sensor assembly part corresponds to asituation wherein the first adhesive layer of the base plate and/or thesensor assembly part has experienced a first degree of radial erosion,e.g. the first adhesive layer is eroded to a first radial distance ofthe first electrode pair but not to a second radial distance of thesecond electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate and/or the sensor assembly part corresponds to asituation wherein the first adhesive layer of the base plate and/or thesensor assembly part has experienced a second degree of radial erosion,e.g. the first adhesive layer is eroded to the second radial distance ofthe second electrode pair but not to a third radial distance of thethird electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data.

In one or more exemplary monitor devices, determination of an operatingstate may be based on one or more fourth parameters, such as fourthprimary parameter and/or fourth secondary parameter of the fourthparameter data.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on afirst criteria set based on the first parameter data and/or the secondparameter data, wherein the operating state is determined to be thefirst operating state if the first criteria set is satisfied. The firstcriteria set may comprise one or more first criteria based on one ormore of first parameter data, second parameter data and third parameterdata. The first criteria set may comprise a first primary criterionbased on the first parameter data. The first criteria set may comprise afirst secondary criterion based on the second parameter data. The firstcriteria set may comprise a first tertiary criterion based on the thirdparameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part may be based ona first threshold set comprising one or a plurality of first thresholdvalues. The first threshold set may comprise one or a plurality ofthreshold values, e.g. to be applied in the first criteria set. Thefirst threshold set may comprise a first primary threshold value. Thefirst threshold set may comprise a first secondary threshold value. Thefirst threshold set may comprise a first tertiary threshold value.

The first criteria set may be given by

-   -   (P_1_1<TH_1_1),    -   (P_2_1>TH_1_2), and    -   (P_3_1>TH_1_3),

wherein P_1_1 is a first primary parameter based on the first parameterdata, TH_1_1 is a first primary threshold value, P_2_1 is a secondprimary parameter based on the second parameter data, TH_1_2 is a firstsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data, and TH_1_3 is a first tertiary thresholdvalue, and wherein the first operating state is indicative of low degreeof radial erosion on the base plate and/or the sensor assembly part. Thefirst threshold values (TH_1_1, TH_1_2 and TH_1_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The first tertiary criterion(P_3_1<TH_1_3) may be omitted in the first criteria set.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate and/or the sensorassembly part.

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate and/or the sensor assembly part.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate and/or the sensor assembly part.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on asecond criteria set based on the second parameter data and/or the thirdparameter data, wherein the operating state is determined to be thesecond operating state if the second criteria set is satisfied. Thesecond criteria set may be based on the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on asecond threshold set comprising one or a plurality of second thresholdvalues. The second threshold set may comprise one or a plurality ofthreshold values, e.g. to be applied in the second criteria set. Thesecond threshold set may comprise a second primary threshold value. Thesecond threshold set may comprise a second secondary threshold value.The second threshold set may comprise a second tertiary threshold value.

The second criteria set may be given by

-   -   (P_1_1<TH_2_1),    -   (P_2_1<TH_2_2), and    -   (P_3_1>TH_2_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_2_1 is a second primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_2_2 is a secondsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_2_3 is a second tertiary threshold value, andwherein the second operating state is indicative of medium degree ofradial erosion on the base plate and/or the sensor assembly part. Thesecond threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The second primary criterion(P_1_1<TH_2_1) and/or the second tertiary criterion (P_3_1>TH_2_3) maybe omitted in the second criteria set.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on adefault criteria set based on the first parameter data, wherein theoperating state is determined to be the default operating state if thedefault criteria set is satisfied, and in accordance with adetermination that the operating state is the default operating state,transmit a default monitor signal comprising monitor data indicative ofthe default operating state of the ostomy appliance.

The default criteria set may be given by

-   -   (P_1_1>TH_D_1),    -   (P_2_1>TH_D_2), and    -   (P_3_1>TH_D_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_D_1 is a default primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_D_2 is a defaultsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_D_3 is a default tertiary threshold value, andwherein the default operating state is indicative of very low or nodegree of radial erosion on the base plate and/or the sensor assemblypart. The default threshold values (TH_D_1, TH_D_2 and TH_D_3) may bethe same or different, e.g. depending on the electrode configuration ofthe base plate and/or the sensor assembly part.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate and/or the sensor assembly part is based on athird criteria set based on the third parameter data, wherein theoperating state is determined to be the third operating state if thethird criteria set is satisfied, and in accordance with a determinationthat the operating state is the third operating state, transmit a thirdmonitor signal comprising monitor data indicative of the third operatingstate of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate and/or the sensor assembly part corresponds to asituation wherein the first adhesive layer of the base plate and/or thesensor assembly part has experienced a third degree of radial erosion,e.g. the first adhesive layer is eroded to the third radial distance ofthe third electrode pair. The third criteria set may be given by

-   -   (P_1_1<TH_3_1),    -   (P_2_1<TH_3_2), and    -   (P_3_1<TH_3_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_3_1 is a third primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_3_2 is a thirdsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_3_3 is a third tertiary threshold value, andwherein the third operating state is indicative of high degree of radialerosion on the base plate and/or the sensor assembly part. The thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The third primary criterion(P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) maybe omitted in the third criteria set.

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair of the base plate and/orthe sensor assembly part. To apply a processing scheme may comprise toobtain fourth parameter data based on the fourth ostomy data, anddetermine an operating state of the base plate and/or the sensorassembly part of the ostomy appliance based on the fourth parameterdata. The monitor device may be configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate and/or the sensor assembly part corresponds to asituation, wherein the fourth electrode pair detects fluid, such asoutput, between the distal surface of first adhesive layer and the skinof the user at a fourth radial distance, and thus there is a high riskof leakage from the ostomy appliance in the fourth operating state.

The fourth criteria set may be given by

-   -   (P_4_1<TH_4_4)

wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair and TH_4_4 is a fourth quaternary threshold value, andwherein the fourth operating state is indicative of high risk of leakagefrom the ostomy appliance.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.Additionally or alternatively, the monitor device housing may be rigidor flexible.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and//or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate and/or the sensor assemblypart. The coupling part and the terminals of the first interface form(at least part of) a first connector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery. Additionally oralternatively, the sensor terminal may change its function if thecharging voltage is sensed at relevant terminals.

The monitor device may comprise a sensor unit with one or more sensor.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a BLUETOOTH transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBLUETOOTH protocol, e.g. BLUETOOTH Low Energy, BLUETOOTH 4.0, BLUETOOTH5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively.

The monitor device may be electrically coupled to the plurality ofelectrodes of the base plate and/or the sensor assembly part. Forexample, the monitor device may be couplable, such as releasablycouplable, to the plurality of electrodes of the base plate and/or thesensor assembly part. The monitor device may be configured to measureone or more resistances between the plurality of electrodes, and detectthe leakage of output based on the measured one or more resistances.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate and/or the sensor assembly partof the ostomy appliance.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system. The docking station may be configured toelectrically and/or mechanically couple the monitor device to thedocking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

Disclosed is a base plate and/or a sensor assembly part of an ostomyappliance. The base plate and/or the sensor assembly part comprises afirst adhesive layer including: a stomal opening with a center point anda proximal surface configured to be attached to a skin surface of auser. In embodiments, the base plate and/or the sensor assembly part maycomprise a masking element arranged on a distal surface of the firstadhesive layer, wherein the masking element may be more insulative, suchas less electrically conductive and/or less moisture-permeable, than thefirst adhesive layer. Additionally or alternatively, the base plateand/or the sensor assembly part may comprise a plurality of electrodesarranged on a distal side of the first adhesive layer, wherein eachelectrode includes a sensing part and a conductor part, wherein themasking element may be arranged between the conductor parts and thefirst adhesive layer.

In embodiments, the sensing parts of each electrode may facilitatedetermining a leak between a skin surface of the user and the base plateand/or the sensor assembly part, and/or the state of the adhesivedevice. Additionally or alternatively, by including a masking elementarranged between the conductor parts and the first adhesive layer, theconductor parts of the electrodes may be insulated from the firstadhesive layer, which may prevent more than one of the conductor partsof the electrodes from shorting together due to moisture absorption ofthe first adhesive layer.

The plurality of electrodes may be formed on a proximal surface of asupport layer. The support layer may increase the structural integrityof the electrodes to, perhaps, reduce the likelihood the electrodes aredamaged and/or broken.

The plurality of electrodes may be printed on the support layer.

The plurality of electrodes may form a first resistive pair ofelectrodes and a second resistive pair of electrodes, wherein eachresistive pair of electrodes may include an electrode part of a groundelectrode. The first and second resistive pairs of the electrodes mayfacilitate determining the adhesion between the base plate and/or thesensor assembly part and the skin surface of a user. By determining theadhesion between the base plate and/or the sensor assembly part and theskin surface of a user, the user may be alerted if the adhesion isdeteriorating.

The moisture content of a respective sensing zone may be indicative ofhow well the first adhesive layer is adhering to the skin surface of auser. To determine the moisture content of a respective sensing zone, aresistance between the electrodes included in the first, second, and/orthird resistive pairs may be sensed by, for example, the monitor device.And, when the resistance between the electrodes included in the first,second, and/or third resistive pairs decreases below a threshold level,the monitor device may send an indication to the user that the adhesionbetween the first adhesive layer and the skin surface of a user may bedeteriorating. In embodiments, when the adhesion between the firstadhesive layer and the skin surface of a user proximal to the thirdresistive pair deteriorates, the monitor device may send a signal to theuser suggesting the user change his/her ostomy appliance and/or baseplate. Additionally or alternatively, when the adhesion between thefirst adhesive layer and the skin surface of a user proximal to thefirst resistive pair and/or second resistive pair deteriorates, themonitor device may send a signal to the user suggesting the user changehis/her ostomy appliance and/or base plate.

In embodiments, the second resistive pair of electrodes may at leastpartially surround the first resistive pair of electrodes. By includinga second resistive pair that at least partially surrounds a firstresistive pair, a velocity of the deterioration of adhesion between thebase plate and/or the sensor assembly part and the skin surface of auser may be determined.

The plurality of electrodes may form a third resistive pair ofelectrodes, wherein the third resistive pair of electrodes includes anelectrode part of a ground electrode.

The third resistive pair of electrodes may at least partially surroundthe second resistive pair of electrodes. By including a third resistivepair that at least partially surrounds the second resistive pair ofelectrodes, and determining a velocity of adhesion deterioration basedon the first and second resistive pairs, a prediction may be made as towhen the adhesion between the skin surface of a user and the base plateand/or the sensor assembly part proximal to the third resistive pair maydeteriorate.

By including different resistive pairs which at least partially surroundone another, a monitor device may determine how quickly the adhesionbetween the first adhesive layer and the skin surface of a user may bedeteriorating. For example, a monitor device may determine that at timet₁ the adhesion between the first adhesive layer and the skin surface ofa user proximal to the first resistive pair is deteriorating by sensinga reduced resistance between the electrodes included in the firstresistive pair. Then, at time t₂ the monitor device may determine theadhesion between the first adhesive layer and the skin surface of a userproximal to the second resistive pair is deteriorating by sensing areduced resistance between the electrodes included in the secondresistive pair. By knowing the distance between the first and secondresistive pairs, the monitor device may calculate a velocity by dividingthe distance between the first and second resistive pairs by thedifference between t₁ and t₂. The computed velocity may then determinehow much time a user has before the adhesion between the first adhesivelayer and the skin surface of a user proximal to the third resistivepair deteriorates, which may be when the user would like to changehis/her ostomy appliance and/or base plate.

In embodiments, at least one of the first resistive pair, the secondresistive pair, and the third resistive pair may be arrangedcircumferentially around the center point the stomal opening of the baseplate and/or the sensor assembly part.

The base plate and/or the sensor assembly part may comprise a firstintermediate element. The first intermediate element may be lesscompliant than the first adhesive layer, e.g. the first intermediateelement may be more rigid than the first adhesive layer. Each electrodemay include a connection part, and the first intermediate element may bearranged between the connection parts and the first adhesive layer. Byincluding the first intermediate element, the connection parts of theelectrodes may be less likely to be damaged and/or broken.

In embodiments, the first intermediate element may facilitate protectingthe terminal elements and/or the connection parts. For example, thefirst intermediate element may be less compliant than the first adhesivelayer, the second adhesive layer, and/or the masking element. By beingless compliant, the first intermediate element may reduce the ability ofthe terminal elements and/or the connection parts to flex. As such, theterminal elements and/or the connection parts may be less likely tobreak due to flexure. In embodiments, the first intermediate element maycomprise at least one of polymeric (e.g. polyurethane, PTFE, PVDF) andceramic (e.g. alumina, silica) materials.

Additionally or alternatively, the first intermediate element may reducethe likelihood that more than one of the terminal elements are shortedtogether and/or more than one of the connection parts are shortedtogether. For example, the first intermediate element may be lessmoisture absorbent than the first adhesive layer and/or the maskingelement. By being less moisture absorbent, the first intermediateelement may prevent moisture (e.g., sweat, output, etc.) from cominginto contact with one or more of the terminal elements and/or theconnection parts via the first adhesive layer and/or the masking elementand, potentially, shorting a combination of the terminal elementstogether and/or a combination of the connection parts together.

In embodiments, each electrode may include a connection part, whereinthe masking element may comprise a plurality of terminal openings, andwherein each terminal opening may overlap a connection part.

In embodiments, wherein the first adhesive layer comprises a pluralityof openings, wherein the masking element comprises a plurality ofopenings, and wherein each opening of the plurality of openings of thefirst adhesive layer overlaps an opening of the plurality of openings ofthe masking element, a sensor point is defined. In embodiments, thesensor points may be used to detect a leakage between a skin surface ofa user and the base plate and/or the sensor assembly part.

In embodiments, the sensor points may be arranged at generally equaldistances from the center point.

The base plate and/or the sensor assembly part may further comprise asecond adhesive layer arranged distally of the plurality of electrodes.The second adhesive layer may protect the electrodes and/or addstructural integrity to the base plate and/or the sensor assembly part.

In embodiments, the first adhesive layer and the second adhesive layermay be comprised of different ratios of one or more of: polyisobutenes,styrene-isoprene-styrene, and/or hydrocolloids. By being comprised ofdifferent ratios of materials, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer and/or the first adhesive layer mayprovide less irritation to the skin surface of a user.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4. The base plate4 is adapted to support an ostomy pouch (not shown). Further, the ostomysystem 1 comprises a monitor device 6 and an accessory device 8 (mobiletelephone). The monitor device 6 is connectable to the base plate 4 viarespective first connectors of the monitor device 6 and base plate 4.The monitor device 6 is configured for wireless communication with theaccessory device 8. Optionally, the accessory device 8 is configured tocommunicate with a server device 10 of the ostomy system 1, e.g. vianetwork 12. The server device 10 may be operated and/or controlled bythe ostomy appliance manufacturer, the accessory device 8, and/or aservice centre. Ostomy data or parameter data based on the ostomy dataare obtained from electrodes/sensors of the ostomy appliance 2 with themonitor device 6. The monitor device 6 processes the ostomy data and/orparameter data based on the ostomy data. Based on the processed ostomydata, the monitor device 6 may determine what monitor data that aretransmitted to the accessory device 8. In the illustrated ostomy system,the accessory device 8 is a mobile phone, however the accessory device 8may be embodied as another handheld device, such as a tablet device, ora wearable, such as a watch or other wrist-worn electronic device.Accordingly, the monitor device 6 is configured to determine andtransmit monitor data to the accessory device 8. The base plate 4comprises a coupling member 14 in the form of a coupling ring 16 forcoupling an ostomy pouch (not shown) to the base plate (two-part ostomyappliance). In alternative embodiments, the ostomy pouch may be formedtogether with the base plate (one-part ostomy appliance). The base platehas a stomal opening 18 with a center point. The size and/or shape ofthe stomal opening 18 is typically adjusted by the user or nurse beforeapplication of the ostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming analternative/additional accessory device of the ostomy system 1. Thedocking station 20 comprises a docking monitor interface including afirst connector 22 configured for electrically and/or mechanicallyconnecting the monitor device 6 to the docking station 20. The dockingmonitor interface may be configured for wirelessly connecting themonitor device to the docking station. The docking station 20 comprisesa user interface 24 for receiving user input and/or providing feedbackto the user on the operational state of the docking station 20. The userinterface 24 may comprise a touch-screen. The user interface 24 maycomprise one or more physical buttons and/or one or more visualindicators, such as light emitting diodes,

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor 101and one or more interfaces, the one or more interfaces including a firstinterface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Inembodiments, the first interface 102 comprises a ground terminal 108, afirst terminal 110, a second terminal 112 and a third terminal 114. Thefirst interface 102 may also comprise a fourth terminal 116 and a fifthterminal 118. The first interface 102 of the monitor device 6 comprisesa coupling part 120 for forming a mechanical connection, such as areleasable coupling between the monitor device and the base plate. Thecoupling part 120 and the terminals 108, 110, 112, 114, 116, and 118 ofthe first interface 102 form (at least part of) a first connector of themonitor device 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 optionally comprises a sensor unit 140 connected tothe processor 101. For example, the sensor unit 140 may comprise atemperature sensor for feeding temperature data to the processor and/ora G-sensor or accelerometer for feeding acceleration data to theprocessor 101. Additionally or alternatively, the sensor unit 140comprises a humidity sensor and/or an acoustic sensor. The sensor unit140 may comprise alternative and/or additional sensors suitable and/orrelevant to an ostomy system as described.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate and/or the sensor assembly part coupled to the firstinterface, the ostomy data comprising first ostomy data from a firstelectrode pair of the base plate and/or the sensor assembly part, secondostomy data from a second electrode pair of the base plate and/or thesensor assembly part, and third ostomy data from a third electrode pairof the base plate and/or the sensor assembly part. The ostomy data maybe stored in the memory 106 and/or processed in the processor 101 inorder to obtain parameter data. The parameter data may be stored in thememory 106. The processor 101 is configured to apply a processingscheme, wherein to apply a processing scheme comprises obtain firstparameter data based on the first ostomy data; obtain second parameterdata based on the second ostomy data; obtain third parameter data basedon the third ostomy data. In other words, the processor 101 isconfigured to obtain first, second and third parameter data based onrespective first, second and third ostomy data. To apply a processingscheme comprises to determine an operating state of the base plateand/or the sensor assembly part of the ostomy appliance based on one ormore, e.g. all, of the first parameter data, the second parameter dataand the third parameter data, wherein the operating state is indicativeof a degree of radial erosion of the base plate and/or the sensorassembly part and/or acute leakage risk for the ostomy appliance. Themonitor device 6 is configured to, in accordance with a determinationthat the operating state is a first operating state, transmit a firstmonitor signal comprising monitor data indicative of the first operatingstate of the base plate and/or the sensor assembly part via the secondinterface; and in accordance with a determination that the operatingstate is a second operating state, transmit a second monitor signalcomprising monitor data indicative of the second operating state of thebase plate and/or the sensor assembly part via the second interface.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200.In embodiments, the first adhesive layer 200 comprises a stomal opening18A, which may form part of the stomal opening 18. As stated above, thestomal opening 18 (see FIG. 1 ) may be adjusted before application toaccommodate the user's stoma, which includes adjusting the stomalopening 18A. During use, the stoma-receiving opening 18, including thestomal opening 18A, is arranged around a user's stoma and a proximalsurface 200B of the first adhesive layer 200 adheres to the skin surfaceof the user in the peristomal area and/or to additional seals, such assealing paste, sealing tape and/or sealing ring.

In embodiments, the base plate 4 comprises a second adhesive layer 202,also denoted rim adhesive layer. As illustrated, the second adhesivelayer 202 may be arranged distally of the first adhesive layer 200.Additionally or alternatively, a portion of the distal surface 200A ofthe first adhesive layer 200, which is not covered by the electrodeassembly 204, may adhere to a portion of the proximal surface 202B ofthe second adhesive layer 202. In embodiments, the second adhesive layer202 may have a second radial extension that is larger than a firstradial extension of the first adhesive layer 200 at least in a firstangular range of the base plate 4.

The first adhesive layer 200 and/or second adhesive layer 202 maycomprise one or more of polyisobutenes, styrene-isoprene-styrene, and/orhydrocolloids. Different ratio of contents may change properties of thefirst and/or second adhesive layers 200, 202. As such, the secondadhesive layer 202 and the first adhesive layer 200 may have differentproperties due to different ratios of polyisobutenes,styrene-isoprene-styrene, and/or hydrocolloids. For example, the secondadhesive layer 202 may provide a stronger attachment to the skincompared to attachment to the skin provided by the first adhesive layer200. Additionally or alternatively, the first adhesive layer may provideless irritation to the skin surface of a user. In embodiments, thesecond adhesive layer 202 may be thinner than the first adhesive layer200. Additionally or alternatively, the second adhesive layer 202 may beless water and/or sweat absorbing than the first adhesive layer 200.Additionally or alternatively, the second adhesive layer 202 may be lessmouldable than the first adhesive layer 200. The second adhesive layer202 may provide a second barrier against leakage.

Additionally or alternatively, the second adhesive layer 202 may be lessmouldable than the first adhesive layer 200. The second adhesive layer202 may provide a second barrier against leakage.

The base plate 4 comprises a plurality of electrodes arranged in anelectrode assembly 204. The electrode assembly 204 is arranged betweenthe first adhesive layer 200 and the second adhesive layer 202. Forexample, the electrode assembly 204 may be arranged on a distal side(e.g., the distal surface 200A) of the first adhesive layer 200 and aproximal side (e.g., the proximal surface 202B) of the second adhesivelayer 202.

The base plate 4 comprises a release liner 206 that is peeled off by theuser prior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 and a coupling ring 209 for coupling an ostomypouch to the base plate 4. The top layer 208 is a protective layerprotecting the second adhesive layer 202 from external strains andstress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the proximalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

As previously described, some parts of the illustrated base plate 4, maybe provided as a separate assembly to be applied to an existing baseplate, e.g. comprising one or more of the components as described, suchas to provide a base plate like the base plate 4 as described. Forexample, a sensor assembly part 700 may be provided, e.g. comprising theelectrode assembly 204, the first connector 211, the first intermediateelement 213, the first adhesive layer 200 and the release liner 206.Additionally, the sensor assembly part 700 may also comprise the secondadhesive layer 202 and/or the top layer 208. It may be envisioned thatthe user may provide a hole in layers of the base plate whereto thesensor assembly part 700 is to be applied, to allow for the firstconnector 211 of the sensor assembly part 700 to protrude through layersof the base plate whereto the sensor assembly part 700 is applied.Alternatively, the sensor assembly part 700 may be applied to the baseplate such that the first connector 211 is positioned outside theperiphery of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate and/or a sensor assembly part. The electrodeassembly 204 comprises a support layer 214 with proximal surface 214Band electrodes 216 arranged on the proximal side of the support layer214. The electrode assembly 204 includes a ground electrode, a firstelectrode, a second electrode, a third electrode, a fourth electrode,and a fifth electrode, wherein each electrode has a respectiveconnection part for connecting the electrodes to respective terminalelements of the monitor interface.

In embodiments, the electrodes 216 are electrically conductive andcomprise at least one of metallic (e.g. silver, copper, gold, titanium,aluminium, stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT,PANI, PPy), and carbonaceous (e.g. carbon black, carbon nanotube, carbonfibre, graphene, graphite) materials. Additionally or alternatively, theelectrodes 216 may be formed using screen-printing, inkjet-printing,direct-ink-writing, pen-plotting, 3D-printing,fused-deposition-modelling, contact-transfer printing, spray painting,chemical vapour depositing, physical vapour depositing,atomic-layer-depositing, wire-bending, and or any other methods known toa person skilled in the art. In embodiments, the electrodes 216 canrequire one of heat-curing, UV-curing, and oxygen-activation.

In embodiments, the support layer 214 may increase the structuralintegrity of the electrodes 216. Additionally or alternatively, thesupport layer 214 may be moisture resistant or moisture transmissive. Inembodiments, the support layer 214 may comprise at least one ofpolymeric (e.g. polyurethane, PTFE, PVDF) and ceramic (e.g. alumina,silica) materials.

Further, electrode assembly 204 comprises a masking element 218 withproximal surface 218B. In embodiments, the masking element 218 may bearranged on the distal surface 200A of the first adhesive layer 200 (seeFIG. 3 ). Additionally or alternatively, the masking element 218 may becomprised of a material that is more insulative (e.g., less electricallyconductive and/or less moisture-permeable) than the first adhesive layer200. In embodiments, the masking element 218 may comprise at least oneof polymeric (e.g. polyurethane, PTFE, PVDF) and ceramic (e.g. alumina,silica) materials. In embodiments, the masking element 218 may cover oroverlap with parts of the electrodes 216 when seen in the axialdirection. As such, the masking layer 218 may at least partiallyinsulate electrode parts of the electrodes 216 from the first adhesivelayer of the base plate 200 and/or the sensor assembly part.

FIG. 5 is a proximal view of proximal surfaces of base plate and/or thesensor assembly part parts of the base plate 4 and/or the sensorassembly part 700 without the first adhesive layer 200 (illustrated inFIG. 3 ) and the release liner 206 (illustrated in FIG. 3 ). The baseplate 4 comprises a first intermediate element 213 on the proximal sideof the electrode assembly, i.e. between the electrode assembly 204 andthe first adhesive layer. The first intermediate element 213 covers theterminal elements of the base plate 4 when seen in the axial directionand protects the first adhesive layer 200 from mechanical stress fromthe terminal elements of the base plate 4 and/or the sensor assemblypart 700.

In embodiments, the first intermediate element 213 may facilitateprotecting the terminal elements 212 and/or the connection parts 222A,224A, 226A, 228A, 230A, 232A (see FIG. 6 ). For example, the firstintermediate element 213 may be less compliant than the first adhesivelayer 200 (depicted in FIG. 3 ), the second adhesive layer 202, and/orthe masking element 218. By being less compliant, the first intermediateelement 213 may reduce the ability of the terminal elements 212 and/orthe connection parts 222A, 224A, 226A, 228A, 230A, 232A to flex. Assuch, the terminal elements 212 and/or the connection parts 222A, 224A,226A, 228A, 230A, 232A may be less likely to break due to flexure. Inembodiments, the first intermediate element 213 may comprise at leastone of polymeric (e.g. polyurethane, PTFE, PVDF) and ceramic (e.g.alumina, silica) materials.

Additionally or alternatively, the first intermediate element 213 mayreduce the likelihood that more than one of the terminal elements 212are shorted together and/or more than one of the connection parts 222A,224A, 226A, 228A, 230A, 232A are shorted together. For example, thefirst intermediate element 213 may be less moisture absorbent than thefirst adhesive layer 200 (depicted in FIG. 3 ) and/or the maskingelement 218. By being less moisture absorbent, the first intermediateelement 213 may prevent moisture (e.g., sweat, output, etc.) from cominginto contact with one or more of the terminal elements 212 and/or theconnection parts 222A, 224A, 226A, 228A, 230A, 232A via the firstadhesive layer 200 and/or the masking element 218 and, potentially,shorting a combination of the terminal elements 212 together and/or acombination of the connection parts 222A, 224A, 226A, 228A, 230A, 232Atogether.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrode assembly204, such as the electrode configuration 220, of the electrode assembly204 comprises a ground electrode 222, a first electrode 224, a secondelectrode 226, a third electrode 228, a fourth electrode 230, and afifth electrode 232. The ground electrode 222 comprises a groundconnection part 222A, and a ground sensing part 222B. The firstelectrode 224 comprises a first connection part 224A. The secondelectrode 226 comprises a second connection part 226A and the thirdelectrode 228 comprises a third connection part 228A. The fourthelectrode 230 comprises a fourth connection part 230A and the fifthelectrode 232 comprises a fifth connection part 232A. In embodiments,the plurality of electrodes 216 may be coupled to the monitor device 6via the connection parts 222A, 224A, 226A, 228A, 230A, 232A. Inparticular, the ground connection part 222A may be connected to theground terminal 108 via the ground terminal 282 (illustrated in FIG. 10), the first connection part 224A may be connected to the first terminal110 via the first terminal 284 (illustrated in FIG. 10 ), the secondconnection part 226A may be connected to the second terminal 112 via thesecond terminal 286 (illustrated in FIG. 10 ), the third connection part228A may be connected to the third terminal 114 via the third terminal288 (illustrated in FIG. 10 ), the fourth connection part 230A may beconnected to the fourth terminal 116 via the fourth terminal 290(illustrated in FIG. 10 ), and the fifth connection part 232A may beconnected to the fifth terminal 116 via the fifth terminal 292(illustrated in FIG. 10 ). In embodiments, the plurality of electrodes216 may be coupled to the monitor device 6 via the connection parts222A, 224A, 226A, 228A, 230A, 232A. As such, the monitor device 6 maymeasure one or more resistances of the plurality of electrodes 216 forvarious purposes as described below. The fourth electrode 230 comprisesfourth sensing parts 230B and the fifth electrode 232 comprises fifthsensing parts 232B. In embodiments, parts of the fourth electrode 230that are not the fourth connection part 230A and/or the fourth sensingparts 230B may be referred to herein as conductor parts of the fourthelectrode 230. Similarly, parts of the fifth electrode 232 that are notthe fifth connection part 232A and/or the fifth sensing parts 232B maybe referred to herein as conductor parts of the fifth electrode 232.Additionally or alternatively, parts of the ground electrode 222 thatare not part of: a resistive pair (e.g., the first, second, and/or thirdresistive pairs 224B, 226B, 228B described in more detail below), theground connection part 222A and/or the ground sensing parts 222B may bereferred to herein as conductor parts of the ground electrode 222.

In embodiments, the first intermediate element 213 (depicted in FIG. 5 )may be arranged between the connection parts 222A, 224A, 226A, 228A,230A, 232A and the first adhesive layer 200. As stated above, byarranging the first intermediate element 213 (depicted in FIG. 5 )between the first adhesive layer 200 and the connection parts 222A,224A, 226A, 228A, 230A, 232A, the connection parts 222A, 224A, 226A,228A, 230A, 232A may be insulated from the first adhesive layer 200. Theground electrode 222 comprises a first electrode part 234 for forming aground for the first electrode 224. The ground electrode 222 comprises asecond electrode part 236 for forming a ground for the second electrode226. The ground electrode 222 comprises a third electrode part 238 forforming a ground for the third electrode 228. The ground electrode 222comprises a fourth electrode part 240 for forming a ground for thefourth electrode 230 and the fifth electrode 232. The fourth electrodepart 240 of the ground electrode 222 comprises ground sensing parts222B.

In view of the foregoing, the first electrode 224 and the firstelectrode part 234 may form a first resistive pair 224B, the secondelectrode 226 and the second electrode part 236 may form a secondresistive pair 226B, and the third electrode 228 and the third electrodepart 238 may form a third resistive pair 228B. Each of the first,second, and third resistive pairs 224B, 226B, 228B may define respectivesensing zones. Each sensing zone may indicate a moisture content of therespective sensing zone.

The moisture content of a respective sensing zone may be indicative ofhow well the first adhesive layer 200 (depicted in FIG. 3 ) is adheringto the skin surface of a user. To determine the moisture content of arespective sensing zone, a resistance between the electrodes included inthe first, second, and/or third resistive pairs 224B, 226B, 228B may besensed by, for example, the monitor device 6 (depicted in FIG. 1 ). And,when the resistance between the electrodes included in the first,second, and/or third resistive pairs 224B, 226B, 228B decreases below athreshold level, the monitor device 6 may send an indication to the userthat the adhesion between the first adhesive layer 200 and the skinsurface of a user may be deteriorating. In embodiments, when theadhesion between the first adhesive layer 200 and the skin surface of auser proximal to the third resistive pair 228B deteriorates, the monitordevice 6 may send a signal to the user suggesting the user to changehis/her ostomy appliance 2 and/or base plate 4. Additionally oralternatively, when the adhesion between the first adhesive layer 200and the skin surface of a user proximal to the first resistive pair 224Band/or second resistive pair 226B deteriorates, the monitor device 6 maysend a signal to the user suggesting the user to change his/her ostomyappliance 2 and/or base plate 4.

As illustrated in FIG. 6 , the second resistive pair 226B may at leastpartially surround the first resistive pair 224B. Additionally oralternatively, the third resistive pair 228B may at least partiallysurround the second resistive pair 226B. Furthermore, in embodiments,one or more of the first, second, and third resistive pairs 224B, 226B,228B may be arranged circumferentially around the stomal opening 18(depicted in FIG. 1 ) and/or around the center point of the stomalopening 18.

By including different resistive pair 224B, 226B, 228B which at leastpartially surround one another, a monitor device 6 may determine howquickly the adhesion between the first adhesive layer 200 and the skinsurface of a user may be deteriorating. For example, a monitor device 6may determine that at time t₁ the adhesion between the first adhesivelayer 200 and the skin surface of a user proximal to the first resistivepair 224B is deteriorating by sensing a reduced resistance between theelectrodes included in the first resistive pair 224B. Then, at time t₂the monitor device 6 may determine the adhesion between the firstadhesive layer 200 and the skin surface of a user proximal to the secondresistive pair 226B is deteriorating by sensing a reduced resistancebetween the electrodes included in the second resistive pair 226B. Byknowing the distance between the first and second resistive pairs 226A,228B, the monitor device 6 may calculate a velocity by dividing thedistance between the first and second resistive pairs 226A, 228B by thedifference between t₁ and t₂. The computed velocity may then determinehow much time a user has before the adhesion between the first adhesivelayer 200 and the skin surface of a user proximal to the third resistivepair 228B deteriorates, which may be when the user would like to changehis/her ostomy appliance 2 and/or base plate 4.

FIG. 7 is a distal view of an exemplary masking element 218. Inembodiments, the masking layer 218 may by arranged between conductorparts of the ground electrode 222, conductor parts of the fourthelectrode 230, and/or conductor parts of the fifth electrode 232. Thatis, as stated above, the conductor parts of the ground electrode 222 areparts of the ground electrode 222 that are not the ground connectionpart 222A and/or the ground sensing parts 222B. Similarly, the conductorparts of the fourth electrode 230 are parts of the fourth electrode 230that are not the fourth connection part 230A and/or the fourth sensingparts 230B and the conductor parts of the fifth electrode 232 are partsof the fifth electrode 232 that are not the fifth connection part 232Aand/or the fifth sensing parts 232B. Further, because the maskingelement 218 may be more insulative than the first adhesive layer 200,the conductor parts of the ground electrode, the fourth electrode, andthe fifth electrode may be insulated from the first adhesive layer 200.

The masking element 218 optionally has a plurality of terminal openings.For example, the masking element 218 may include one, two, three, four,five, six, seven, etc. terminal openings. In embodiments, the pluralityof terminal openings comprises a ground terminal opening 242, a firstterminal opening 244, a second terminal opening 246, a third terminalopening 248, a fourth terminal opening 250, and a fifth terminal opening252. The terminal openings 242, 244, 246, 248, 250, 252 of the maskingelement 218 are configured to overlap (that is, axially align) withrespective connection parts 222A, 224A, 226A, 228A, 230A, 232A of theelectrodes of the electrode assembly. For example, connection part 222Amay overlap the first terminal opening 244, connection part 224A mayoverlap the second terminal opening 244, connection part 226A mayoverlap the third terminal opening 246, connection part 228A may overlapthe fourth terminal opening 250, connection part 230A may overlap thefifth terminal opening 252, and connection part 232A may overlap thesixth terminal opening 252. While the masking element 218 depicts sixterminal openings, in other embodiments, the masking element 218 mayinclude more or fewer terminal openings.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254. Each primary sensor point opening is configuredto overlap (that is, axially align with) a ground sensing part 222B ofthe ground electrode 222 and/or a fourth sensing part 230B of the fourthelectrode 230 of the electrode configuration 220. More specifically, inembodiments, the primary sensor point openings shown within dotted line254 comprise, in the illustrated exemplary masking element, five primaryfirst sensor point openings 254A each configured to overlap a groundsensing part 222B of the ground electrode 222. In addition, the primarysensor point openings shown within dotted line 254 comprise, in theillustrated exemplary masking element, four primary second sensor pointopenings 254B each configured to overlap a fourth sensing part 230B ofthe fourth electrode 230. In embodiments, each of the primary sensorpoint openings shown within dotted line 254 may be equal distances froma center point of the stomal opening 18. Alternatively, one or more ofthe primary sensor point openings shown within dotted line 254 may bedifferent distances from a center point of the stomal opening 18. Whilethe illustrated embodiment depicts five primary first sensor pointopenings 254A in the dotted line 254, in other embodiments, the maskingelement 218 includes more or fewer than five primary first sensor pointopenings 254A in the dotted line 254. Additionally or alternatively,while the illustrated embodiment depicts four primary second sensorpoint openings 254B in the dotted line 254, in other embodiments, themasking element 218 includes more or fewer than four primary secondsensor point openings 254B in the dotted line 254.

Additionally or alternatively, the sensor point openings comprisesecondary sensor point openings shown within dotted line 256. Eachsecond sensor point opening is configured to overlap a fourth sensingpart 230B of the fourth electrode 230 and/or a fifth sensing part 232Bof the fifth electrode 232 of the electrode configuration 220. Morespecifically, in embodiments, the secondary sensor point openings shownwithin dotted line 256 comprise, in the illustrated exemplary maskingelement, five secondary first sensor point openings 256A each configuredto overlap a fifth sensing part 232B of the fifth electrode 232. Inaddition, the secondary sensor point openings shown within dotted line256 comprise, in the illustrated exemplary masking element, foursecondary second sensor point openings 256B each configured to overlap afourth sensing part 230B of the fourth electrode 230. In embodiments,each of the secondary sensor point openings shown within dotted line 256may be equal distances from a center point of the stomal opening 18.Alternatively, one or more of the secondary sensor point opening shownwithin dotted line 256 may be different distances from a center point ofthe stomal opening 18. In embodiments, the secondary sensor pointopenings shown within dotted line 256 may be substantially the samedistance from a center point of the stomal opening 18 as the primarysensor point openings shown within dotted line 254. Alternatively, oneor more of the secondary sensor point openings shown within dotted line256 may be different distance(s) from a center point of the stomalopening 18 as one or more of the primary sensor point openings shownwithin dotted line 254. While the illustrated embodiment depicts fivesecondary first sensor point openings 256A in the dotted line 256, inother embodiments, the masking element 218 includes more or fewer thanfive secondary first sensor point openings 256A in the dotted line 256.Additionally or alternatively, while the illustrated embodiment depictsfour secondary second sensor point openings 256B in the dotted line 256,in other embodiments, the masking element 218 includes more or fewerthan four secondary second sensor point openings 256B in the dotted line256.

Additionally or alternatively, the sensor point openings comprisetertiary sensor point openings shown within dotted line 258. Eachtertiary sensor opening is configured to overlap a fifth sensing part232B of the fifth electrode 232 and/or a ground sensing part 222B of theground electrode 222 of the electrode configuration 220. Morespecifically, in embodiments, he tertiary sensor point openings shownwithin dotted line 258 comprise, in the illustrated exemplary maskingelement, five tertiary first sensor point openings 258A each configuredto overlap a fifth sensing part 232B of the fifth electrode 232. Inaddition, the tertiary sensor point openings shown within dotted line258 comprise, in the illustrated exemplary masking element, fourtertiary second sensor point openings 258B each configured to overlap aground sensing part 222B of the ground electrode 222. In embodiments,each of the tertiary sensor point openings shown within dotted line 258may be equal distances from a center point of the stomal opening 18.Alternatively, one or more of the tertiary sensor point opening shownwithin dotted line 258 may be different distances from a center point ofthe stomal opening 18. In embodiments, the tertiary sensor pointopenings shown within dotted line 258 may be substantially the samedistance from a center point of the stomal opening 18 as the primarysensor point openings shown within dotted line 254. Alternatively, oneor more of the tertiary sensor point openings shown within dotted line258 may be different distance(s) from a center point of the stomalopening 18 as one or more of the primary sensor point openings shownwithin dotted line 254. Additionally or alternatively, the tertiarysensor point openings shown within dotted line 258 may be substantiallythe same distance from a center point of the stomal opening 18 as thesecondary sensor point openings shown within dotted line 256.Alternatively, one or more of the tertiary sensor point openings shownwithin dotted line 258 may be different distance(s) from a center pointof the stomal opening 18 as one or more of the secondary sensor pointopenings shown within dotted line 256. While the illustrated embodimentdepicts five tertiary first sensor point openings 258A in the dottedline 258, in other embodiments, the masking element 218 includes more orfewer than five tertiary first sensor point openings 258A in the dottedline 258. Additionally or alternatively, while the illustratedembodiment depicts four tertiary second sensor point openings 258B inthe dotted line 258, in other embodiments, the masking element 218includes more or fewer than four tertiary second sensor point openings258B in the dotted line 258.

While the primary sensor point openings shown within dotted line 254,secondary sensor point openings shown within dotted line 256, andtertiary sensor point openings shown within dotted line 258 are evenlydistributed angularly about the stomal opening 18, in other embodiments,the primary sensor point openings shown within dotted line 254,secondary sensor point openings shown within dotted line 256, andtertiary sensor point openings shown within dotted line 258 may beunevenly distributed angularly about the stomal opening 18 and/orfocused within an angular range about the stomal opening 18 (e.g., 30degrees-330 degrees). However, these are only examples and not meant tobe limiting. Additionally or alternatively, while the illustratedembodiment depicts three sectors of sensor point openings (i.e., theprimary sensor point openings, the secondary sensor point openings, andthe tertiary sensor point openings), in alternative embodiments, themasking element 218 may include more or fewer sectors of sensor pointsopenings. Additionally or alternatively, each sector may be unevenlydistributed about the center point of the stomal opening 18, each sectormay span different angular ranges, which may or may not be the samebetween the sectors, and/or may have different starting angles and/ordifferent ending angles.

FIG. 8 is a distal view of an exemplary first adhesive layer 200 andFIG. 9 is a proximal view of the first adhesive layer of FIG. 8 . Thefirst adhesive layer 200 has a plurality of sensor point openings. Thesensor point openings of the first adhesive layer comprise primarysensor point openings shown within dotted line 260. Each primary sensorpoint opening is configured to overlap a ground sensing part 222B of theground electrode 222 and/or a fourth sensing part 230B of the fourthelectrode 230 of the electrode configuration 220. More specifically, inembodiments, the primary sensor point openings shown within dotted line260 comprise, in the illustrated exemplary first adhesive layer 200,five primary first sensor point openings 260A each configured to overlapa ground sensing part 222B of the ground electrode 222. In addition, theprimary sensor point openings shown within dotted line 260 comprise, inthe illustrated exemplary first adhesive layer 200, four primary secondsensor point openings 260B each configured to overlap a fourth sensingpart 230B of the fourth electrode 230. In embodiments, each of theprimary sensor point openings shown within dotted line 260 may be equaldistances from a center point of the stomal opening 18. Alternatively,one or more of the primary sensor point opening shown within dotted line260 may be different distances from a center point of the stomal opening18. While the illustrated embodiment depicts five primary first sensorpoint openings 260A in the dotted line 260, in other embodiments, thefirst adhesive layer 200 includes more or fewer than five primary firstsensor point openings 260A in the dotted line 260. Additionally oralternatively, while the illustrated embodiment depicts four primarysecond sensor point openings 260B in the dotted line 260, in otherembodiments, the first adhesive layer 200 includes more or fewer thanfour primary second sensor point openings 260B in the dotted line 260.

Additionally or alternatively, the sensor point openings of the firstadhesive layer comprise secondary sensor point openings shown withindotted line 262. Each second sensor point opening is configured tooverlap a fourth sensing part 230B of the fourth electrode 230 and/or afifth sensing part 232B of the fifth electrode 232 of the electrodeconfiguration 220. More specifically, in embodiments, the secondarysensor point openings shown within dotted line 262 comprise, in theillustrated exemplary first adhesive layer 200, five secondary firstsensor point openings 262A each configured to overlap a fifth sensingpart 232B of the fifth electrode 232. In addition, the secondary sensorpoint openings shown within dotted line 262 comprise, in the illustratedexemplary first adhesive layer 200, four secondary second sensor pointopenings 262B each configured to overlap a fourth sensing part 230B ofthe fourth electrode 230. In embodiments, each of the secondary sensorpoint openings shown within dotted line 262 may be equal distances froma center point of the stomal opening 18. Alternatively, one or more ofthe secondary sensor point opening shown within dotted line 262 may bedifferent distances from a center point of the stomal opening 18. Inembodiments, the secondary sensor point openings shown within dottedline 262 may be substantially the same distance from a center point ofthe stomal opening 18 as the primary sensor point openings shown withindotted line 260. Alternatively, one or more of the secondary sensorpoint openings shown within dotted line 262 may be different distance(s)from a center point of the stomal opening 18 as one or more of theprimary sensor point openings shown within dotted line 260. While theillustrated embodiment depicts five secondary first sensor pointopenings 262A in the dotted line 262, in other embodiments, the firstadhesive layer 200 includes more or fewer than five secondary firstsensor point openings 262A in the dotted line 262. Additionally oralternatively, while the illustrated embodiment depicts four secondarysecond sensor point openings 262B in the dotted line 262, in otherembodiments, the first adhesive layer 200 includes more or fewer thanfour secondary second sensor point openings 262B in the dotted line 262.

Additionally or alternatively, the sensor point openings of the firstadhesive layer 200 comprise tertiary sensor point openings shown withindotted line 264. Each tertiary sensor opening is configured to overlap afifth sensing part 232B of the fifth electrode 232 and/or a groundsensing part 222B of the ground electrode 222 of the electrodeconfiguration 220. More specifically, in embodiments, the tertiarysensor point openings shown within dotted line 264 comprise, in theillustrated exemplary first adhesive layer 200, five tertiary firstsensor point openings 264A each configured to overlap a fifth sensingpart 232B of the fifth electrode 232. In addition, the tertiary sensorpoint openings shown within dotted line 264 comprise, in the illustratedexemplary first adhesive layer 200, four tertiary second sensor pointopenings 264B each configured to overlap a ground sensing part 222B ofthe ground electrode 222. In embodiments, each of the tertiary sensorpoint openings shown within dotted line 264 may be equal distances froma center point of the stomal opening 18. Alternatively, one or more ofthe tertiary sensor point opening shown within dotted line 264 may bedifferent distances from a center point of the stomal opening 18. Inembodiments, the tertiary sensor point openings shown within dotted line264 may be substantially the same distance from a center point of thestomal opening 18 as the primary sensor point openings shown withindotted line 260. Alternatively, one or more of the tertiary sensor pointopenings shown within dotted line 264 may be different distance(s) froma center point of the stomal opening 18 as one or more of the primarysensor point openings shown within dotted line 260. Additionally oralternatively, the tertiary sensor point openings shown within dottedline 264 may be substantially the same distance from a center point ofthe stomal opening 18 as the secondary sensor point openings shownwithin dotted line 262. Alternatively, one or more of the tertiarysensor point openings shown within dotted line 264 may be differentdistance(s) from a center point of the stomal opening 18 as one or moreof the secondary sensor point openings shown within dotted line 262.While the illustrated embodiment depicts five tertiary first sensorpoint openings 264A in the dotted line 264, in other embodiments, thefirst adhesive layer 200 includes more or fewer than five tertiary firstsensor point openings 264A in the dotted line 264. Additionally oralternatively, while the illustrated embodiment depicts four tertiarysecond sensor point openings 264B in the dotted line 264, in otherembodiments, the first adhesive layer 200 includes more or fewer thanfour tertiary second sensor point openings 264B in the dotted line 264.

Additionally or alternatively, while the illustrated embodiment depictsthree sectors of sensor point openings (i.e., the primary sensor pointopenings, the secondary sensor point openings, and the tertiary sensorpoint openings), in alternative embodiments, the first adhesive layer200 may include more or fewer sectors of sensor points openings.Additionally or alternatively, each sector may be unevenly distributedabout the center point of the stomal opening 18, each sector may spandifferent angular ranges, which may or may not be the same between thesectors, and/or may have different starting angles and/or differentending angles.

In view of the foregoing, the primary sensor point openings shown withindotted line 254 of the masking element 218 (depicted in FIG. 7 ) mayoverlap the primary sensor point openings shown within dotted line 260of the first adhesive layer 200. More specifically, each of the fiveprimary first sensor point openings 254A may overlap a respective one ofthe five primary first sensor point openings 260A. As such, the groundsensor points 222B, which the five primary first sensor point openings254A and the five primary first sensor point openings 260A overlap, maybe exposed in an axial direction from the proximal surface 200B of thefirst adhesive layer 200. Furthermore, each of the four primary secondsensor point openings 254B may overlap a respective one of the fourprimary second sensor point openings 260B. As such, the fourth sensorpoints 230B, which the four primary second sensor point openings 254Band the four primary second sensor point openings 260B overlap, may beexposed in an axial direction from the proximal surface 200B of thefirst adhesive layer 200. In embodiments, when output spans or bridgesfrom a ground sensor point 222B to a fourth sensor point 230B, a leakmay be detected by, for example, the monitor device 6. Morespecifically, a drop in resistance may be sensed between a ground sensorpoint 222B and a fourth sensor point 230B by the monitor device 6 inresponse to output spanning and/or bridging from a ground sensor point222B to a fourth sensor point 230B.

Additionally or alternatively, the second sensor point openings shownwithin dotted line 256 of the masking element 218 (depicted in FIG. 7 )may overlap the second sensor point openings shown within dotted line262 of the first adhesive layer 200. More specifically, each of the fivesecondary first sensor point openings 256A may overlap a respective oneof the five secondary first sensor point openings 262A. As such, thefifth sensor points 232B, which the five secondary first sensor pointopenings 256A and the five secondary first sensor point openings 262Aoverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. Furthermore, each of the foursecondary second sensor point openings 256B may overlap a respective oneof the four secondary second sensor point openings 262B. As such, thefourth sensor points 230B, which the four secondary second sensor pointopenings 256B and the four secondary second sensor point openings 262Boverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. In embodiments, when output spansor bridges from a fifth sensor point 232B to a fourth sensor point 230B,a leak may be detected by, for example, the monitor device 6. Morespecifically, a drop in resistance may be sensed between a fifth sensorpoint 232B and a fourth sensor point 230B by the monitor device 6 inresponse to output spanning and/or bridging from a fifth sensor point232B to a fourth sensor point 230B.

Additionally or alternatively, the tertiary sensor point openings shownwithin dotted line 258 of the masking element 218 (depicted in FIG. 7 )may overlap the tertiary sensor point openings shown within dotted line264 of the first adhesive layer 200. More specifically, each of the fivetertiary first sensor point openings 258A may overlap a respective oneof the five tertiary first sensor point openings 264A. As such, theground sensor points 222B, which the five tertiary first sensor pointopenings 258A and the five tertiary first sensor point openings 264Aoverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. Furthermore, each of the fourtertiary second sensor point openings 258B may overlap a respective oneof the four tertiary second sensor point openings 264B. As such, thefifth sensor points 232B, which the four tertiary second sensor pointopenings 258B and the four tertiary second sensor point openings 264Boverlap, may be exposed in an axial direction from the proximal surface200B of the first adhesive layer 200. In embodiments, when output spansor bridges from a ground sensor point 222B to a fifth sensor point 232B,a leak may be detected by, for example, the monitor device 6. Morespecifically, a drop in resistance may be sensed between a ground sensorpoint 222B and a fifth sensor point 232B by the monitor device 6 inresponse to output spanning and/or bridging from a ground sensor point222B to a fifth sensor point 232B.

FIG. 10 is a more detailed distal view of a part of the base plate 4and/or the sensor assembly part 700. Monitor interface of the base plateand/or the sensor assembly part comprises the first connector 211. Thefirst connector 211 comprises coupling part 210 configured to releasablycouple the monitor device to the base plate and/or the sensor assemblypart and thus forming a releasable coupling. The first connector221/monitor interface comprises a plurality of terminals formed byrespective terminal elements for forming respective electricalconnections with respective terminals of the monitor device.

In embodiments, the plurality of terminals of the first connector 211 ofthe monitor interface comprises a ground terminal element 282 forming aground terminal 282A, a first terminal element 284 forming a firstterminal 284A, a second terminal element 286 forming a second terminal286A, and a third terminal element 288 forming a third terminal 288A.The monitor interface optionally comprises a fourth terminal element 290forming a fourth terminal 290A and/or a fifth terminal element 292forming a fifth terminal 292A. The terminal elements 282, 284, 286, 288,290, 292 contact respective connection parts 222A, 224A, 226A, 228A, 230a, 232A of electrodes 222, 224, 226, 228, 230, 232. he use of the terms“first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not imply any particular order, but are included toidentify individual elements. Moreover, the use of the terms “first”,“second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc.does not denote any order or importance, but rather the terms “first”,“second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc.are used to distinguish one element from another. Note that the words“first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used here and elsewhere for labelling purposes onlyand are not intended to denote any specific spatial or temporalordering. Furthermore, the labelling of a first element does not implythe presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications and equivalents.

Embodiments of the present disclosure are set out in the followingitems:

1. A sensor assembly part of an ostomy appliance, the sensor assemblypart comprising:

-   -   a first adhesive layer including: a stomal opening with a center        point and a proximal surface configured to be attached to a skin        surface of a user;    -   a masking element arranged on a distal surface of the first        adhesive layer, wherein the masking element is more insulative        than the first adhesive layer; and    -   a plurality of electrodes arranged on a distal side of the first        adhesive layer, each electrode including a sensing part and a        conductor part, wherein the masking element is arranged between        the conductor parts and the first adhesive layer.

2. The sensor assembly part of item 1, the plurality of electrodes beingformed on a proximal surface of a support layer.

3. The sensor assembly part of item 2, the plurality of electrodes beingprinted on the support layer.

4. The sensor assembly part of any of items 1-3, the plurality ofelectrodes forming a first resistive pair of electrodes and a secondresistive pair of electrodes, wherein each resistive pair of electrodesincludes an electrode part of a ground electrode.

5. The sensor assembly part of any of items 1-4, wherein the secondresistive pair of electrodes at least partially surrounds the firstresistive pair of electrodes.

6. The sensor assembly part of any of items 1-5 as dependent on item 4,the plurality of electrodes forming a third resistive pair ofelectrodes, wherein the third resistive pair of electrodes includes anelectrode part of a ground electrode.

7. The sensor assembly part of any of items 1-6 as dependent on item 6,wherein the third resistive pair of electrodes at least partiallysurrounds the second resistive pair of electrodes.

8. The sensor assembly part of any of items 1-7 as dependent on item 6,wherein at least one of the first resistive pair, the second resistivepair, and the third resistive pair are arranged circumferentially aroundthe center point.

9. The sensor assembly part of any of items 1-8, further comprising afirst intermediate element, wherein the first intermediate element isless compliant than the first adhesive layer, wherein each electrodeincludes a connection part and wherein the first intermediate element isarranged between the connection parts and the first adhesive layer.

10. The sensor assembly part of any of items 1-9, wherein each electrodeincludes a connection part, wherein the masking element comprises aplurality of terminal openings, and wherein each terminal openingoverlaps a connection part.

11. The sensor assembly part of any of items 1-10, wherein the firstadhesive layer comprises a plurality of openings, wherein the maskingelement comprises a plurality of openings, and wherein each opening ofthe plurality of openings of the first adhesive layer overlaps anopening of the plurality of openings of the masking element for form asensor point.

12. The sensor assembly part of any of items 1-11 as dependent on item10, wherein the sensor points are arranged at generally equal distancesfrom the center point.

13. The sensor assembly part of any of items 1-12, further comprising asecond adhesive layer arranged distally of the plurality of electrodes.

14. The sensor assembly part of any of items 1-13 as dependent on item13, wherein the first adhesive layer and the second adhesive layer arecomprised of different ratios of one or more of: polyisobutenes,styrene-isoprene-styrene, and/or hydrocoloids.

LIST OF REFERENCES

1 ostomy system

2 ostomy appliance

4 base plate

6 monitor device

8 accessory device

10 server device

12 network

14 coupling member

16 coupling ring

18 stomal opening

20 docking station

22 first connector

24 user interface

100 monitor device housing

101 processor

102 first interface

104 second interface

106 memory

108 ground terminal of monitor device

110 first terminal of monitor device

112 second terminal of monitor device

114 third terminal of monitor device

116 fourth terminal of monitor device

118 fifth terminal of monitor device

120 coupling part

121 power unit

122 antenna

124 wireless transceiver

126 loudspeaker

128 haptic feedback element

140 sensor unit

200 first adhesive layer

200A distal surface of first adhesive layer

200B proximal surface of first adhesive layer

202 second adhesive layer

202A distal surface of second adhesive layer

202B proximal surface of second adhesive layer

204 electrode assembly

206 release liner

206A distal surface of the release liner

208 top layer

208A distal surface of the top layer

209 coupling ring

210 coupling part of first connector

211 first connector

212 terminals of first connector

213 first intermediate element

213A distal surface of first intermediate element

213B proximal surface of first intermediate element

214 support layer of electrode assembly

214B proximal surface of support layer

216 electrodes of electrode assembly

218 masking element

218A distal surface of masking element

218B proximal surface of masking element

220 electrode configuration

222 ground electrode

222A ground connection part

222B ground sensing part

224 first electrode

224A first connection part

224B first resistive pair

226 second electrode

226A second connection part

226B second resistive pair

228 third electrode

228A third connection part

228B third resistive pair

230 fourth electrode

230A fourth connection part

230B fourth sensing part

232 fifth electrode

232A fifth connection part

232B fifth sensing part

234 first electrode part of the ground electrode

236 second electrode part of the ground electrode

238 third electrode part of the ground electrode

240 fourth electrode part of the ground electrode

242 ground terminal opening

244 first terminal opening

246 second terminal opening

248 third terminal opening

250 fourth terminal opening

252 fifth terminal opening

254 primary sensor point openings of masking element

254A primary first sensor point opening

254B primary second sensor point opening

256 secondary sensor point openings of masking element

256A secondary first sensor point opening

256B secondary second sensor point opening

258 tertiary sensor point openings of masking element

258A tertiary first sensor point opening

258B tertiary second sensor point opening

260 primary sensor point openings of first adhesive layer

260A primary first sensor point opening

260B primary second sensor point opening

262 secondary sensor point openings of first adhesive layer

262A secondary first sensor point opening

262B secondary second sensor point opening

264 tertiary sensor point openings of first adhesive layer

264A tertiary first sensor point opening

264B tertiary second sensor point opening

282 ground terminal element

282A ground terminal

284 first terminal element

284A first terminal

286 second terminal element

286A second terminal

288 third terminal element

288A third terminal

290 fourth terminal element

290A fourth terminal

292 fifth terminal element

292A fifth terminal

700 sensor assembly part

The invention claimed is:
 1. A base plate of an ostomy appliance, thebase plate comprising: a first adhesive layer including: a stomalopening with a center point and a proximal surface configured to beattached to a skin surface of a user; a masking element arranged on adistal surface of the first adhesive layer, wherein the masking elementis more insulative than the first adhesive layer; and a plurality ofelectrodes arranged entirely between a proximal surface of a supportlayer and a distal side of the first adhesive layer, each electrodeincluding a sensing part and a conductor part, wherein the maskingelement is arranged between the conductor parts of the plurality ofelectrodes and the first adhesive layer, and wherein the masking elementis not arranged between the sensing parts of the plurality of electrodesand the first adhesive layer.
 2. The base plate of claim 1, wherein theplurality of electrodes is printed on the support layer.
 3. The baseplate of claim 1, wherein the plurality of electrodes forms a firstresistive pair of electrodes and a second resistive pair of electrodes,wherein each resistive pair of electrodes includes an electrode part ofa ground electrode.
 4. The base plate of claim 3, wherein the secondresistive pair of electrodes at least partially surrounds the firstresistive pair of electrodes.
 5. The base plate of claim 3, wherein theplurality of electrodes forms a third resistive pair of electrodes,wherein the third resistive pair of electrodes includes an electrodepart of a ground electrode.
 6. The base plate of claim 5, wherein thethird resistive pair of electrodes at least partially surrounds thesecond resistive pair of electrodes.
 7. The base plate of claim 5,wherein at least one of the first resistive pair, the second resistivepair, and the third resistive pair is arranged circumferentially aroundthe center point.
 8. The base plate of claim 1, further comprising afirst intermediate element, wherein the first intermediate element isless compliant than the first adhesive layer, wherein each electrodeincludes a connection part and wherein the first intermediate element isarranged between the connection parts and the first adhesive layer. 9.The base plate of claim 1, wherein each electrode includes a connectionpart, wherein the masking element comprises a plurality of terminalopenings, and wherein each terminal opening overlaps a connection part.10. The base plate of claim 1, wherein the first adhesive layercomprises a plurality of openings, wherein the masking element comprisesa plurality of openings, and wherein each opening of the plurality ofopenings of the first adhesive layer overlaps an opening of theplurality of openings of the masking element to form a sensor point. 11.The base plate of claim 10, wherein the sensor points are arranged atgenerally equal distances from the center point.
 12. The base plate ofclaim 1, further comprising a second adhesive layer arranged distally ofthe plurality of electrodes.
 13. The base plate of claim 12, wherein thefirst adhesive layer and the second adhesive layer are comprised ofdifferent ratios of one or more of: polyisobutenes,styrene-isoprene-styrene, and/or hydrocolloids.
 14. A base plate of anostomy appliance, the base plate comprising: a first adhesive layerincluding: a stomal opening with a center point and a proximal surfaceconfigured to be attached to a skin surface of a user; a masking elementarranged on a distal surface of the first adhesive layer, wherein themasking element is more insulative than the first adhesive layer; and aplurality of electrodes arranged entirely between a proximal surface ofa support layer and a distal side of the first adhesive layer in anaxial direction, each electrode including a sensing part and a conductorpart, wherein the masking element is arranged between the conductorparts of the plurality of electrodes and the first adhesive layer, andwherein the masking element is not arranged between the sensing parts ofthe plurality of electrodes and the first adhesive layer.
 15. The baseplate of claim 14, further comprising a first intermediate element,wherein the first intermediate element is less compliant than the firstadhesive layer, wherein each electrode includes a connection part andwherein the first intermediate element is arranged between theconnection parts and the first adhesive layer.
 16. The base plate ofclaim 14, wherein each electrode includes a connection part, wherein themasking element comprises a plurality of terminal openings, and whereineach terminal opening overlaps a connection part.
 17. The base plate ofclaim 14, wherein: the first adhesive layer comprises a plurality ofopenings; the masking element comprises a plurality of openings; andeach opening of the plurality of openings of the first adhesive layeroverlaps an opening of the plurality of openings of the masking elementto form a sensor point.
 18. The base plate of claim 17, wherein thesensor points are arranged at generally equal distances from the centerpoint.
 19. The base plate of claim 14, further comprising a secondadhesive layer arranged distally of the plurality of electrodes.
 20. Thebase plate of claim 19, wherein the first adhesive layer and the secondadhesive layer are comprised of different ratios of one or more of:polyisobutenes, styrene-isoprene-styrene, and/or hydrocolloids.